The Effect of Non-Viscous Fibre Supplementation on Glycemic Control in Individuals With Diabetes Mellitus: A Systematic Review & Meta-analysis of RCTs
试验速览
- 阶段
- 不适用
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Purpose of Study (The Effect of Non-Viscous Fibre Supplementation on Glycemic Control (NVFS & GC) in Individuals with Diabetes Mellitus.
Regardless of the remarkable advancement in pharmacotherapy, diabetes mellitus remains a major concern with more than 300 millions living with its complications including CVD. Nutrition is a cornerstone in diabetes management, and increasing total dietary fibre have been shown to decrease HbA1c, fasting glucose, fasting insulin, fructosamine, and HOMA-IR. However, the main underlying mechanism is still not fully understood, and the specific type and proportion of fibre supplementation to be recommended for such individuals is still controversial.
Currently, the available findings/ results from small RCTs are inconsistent. The systematic review method depends on combining data from many small studies in order a pooled estimate of the pooled effect. The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) assessing the effect of non-viscous fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus. We hope the findings of this study will play a role in developing the nutritional guidelines for individuals with diabetes mellitus.
详细描述
Background: High fibre diets have been recommended for individuals with diabetes mellitus. However, the findings on the effect of non-viscous fibre supplementation such as inulin, wheat bran and resistant starch on glycemic control in individuals with diabetes are inconsistent.
Objective: In order to improve the evidence-based guidelines for diabetes mellitus, we will conduct a systematic review and meta-analysis to assess evidence from randomized controlled trials (RCTs) on the effect of non-viscous fibre supplementation on glycemic control in individuals with diabetes.
Design: Cochrane handbook for systematic review of interventions will be used for planning and conducting this meta-analysis. The reporting will follow the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines.
Data sources: MEDLINE, EMBASE, the Cochrane Central Register for Controlled Trials will be searched using appropriate pre-determined search terms.
Study selection: All the included trials must be randomized, controlled, with duration of ≥ 3 weeks investigating the effect of supplementing diet with non-viscous fiber on glycemic control outcomes in individuals with diabetes mellitus. Acute studies, non-randomized, not appropriately controlled studies will be excluded. Both isocaloric and non-isocaloric will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomized
- •Properly controlled
- •≥ 3 weeks
- •Non-viscous fibre supplementation intervention
- •Glycemic control endpoints
- •Individuals with DM
排除标准
- •Non-randomized
- •Not controlled
- •< 3 weeks
- •Viscous fibre supplementation as intervention or placebo
- •Healthy individuals or individuals with conditions other than DM
结局指标
主要结局
HbA1c
时间窗: ≥ 3 weeks
Glycated Hemoglobin A1C
次要结局
- HOMA-IR(≥ 3 weeks)
- FG(≥ 3 weeks)
- FI(≥ 3 weeks)
- Fructomsamine(≥ 3 weeks)